Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-01-01 @ 5:08 AM
Study NCT ID:
NCT05924906
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-03
First Post:
2023-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Escalation and Expansion Study of NB002 in Participants With Advanced or Metastatic Solid Tumors
Sponsor:
Suzhou Neologics Bioscience Co., Ltd.
Organization:
Study Overview
Official Title:
Phase 1a/1b, First-in-Human, Open Label, Dose Escalation and Dose Expansion Study of NB002, a Multifunctional TIM-3 Blocking Antibody, in Subjects With Advanced or Metastatic Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a first-in-human, multicenter, open label, uncontrolled, non-randomized, phase 1a/1b study, to evaluate the safety, tolerability, and preliminary antitumor activity of NB002 in subjects with advanced solid tumors.
Detailed Description:
This study is a first-in-human, multicenter, open-label, uncontrolled, non-randomized, phase 1a/1b study. The study consists of a dose escalation part and a dose expansion part. In the escalation part, the primary objectives are to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) to establish a preliminary recommended Phase 2 dose (RP2D) and/or a maximum tolerated dose (MTD) or maximum administered dose (MAD) of NB002. The expansion part is to further evaluate the safety and tolerability of NB002 at the RDE dose established in the dose escalation part and to explore antitumor activity in the selected population. All subjects will be treated with NB002 via IV infusion at predefined dose levels Q3W on Day 1 of each 21-day Cycle.
The design of the dose escalation part will be provided below. Further details on dose expansion part will be updated later once more information on potentially benefiting tumor types is confirmed.
The design of the dose escalation part will be provided below. Further details on dose expansion part will be updated later once more information on potentially benefiting tumor types is confirmed.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: